S100β and Neuron Specific Enolase Levels in Liver Transplantation

NCT03453047 | Completed

• 1 other identifier: LIVER
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Several neurological problems which include both central nervous system and peripheral nervous system can occur as a result of acute liver failure or severe chronic liver failure. The main reason of cerebral damage in liver failure is cellular metabolic changes, long term neuro-inflammation status, activation of brain microglia, accumulation of manganese and ammonia besides acute and severe hyperammoniemia that triggers systemic inflammation. Examples of neurological complications of serious hepatocellular failure are hepatic encephalopathy, diffuse brain edema, Wilson disease, hepatic myelopathy, acquired hepatocerebral degeneration; Parkinsonism induced cirrhosis and osmatic demyelinization. Attentive neurological evaluation is of high importance in order to define seriousness level and distribution of neurologic disorders besides current treatable anomalies and potentially prescribe postoperative prognosis. S100β is released by astrocytes in brain damage. S100β increases in the beginning of brain damage so it can be used to diagnose early stage brain damage. Neuron specific enolase (NSE) acts as intracytoplasmic enzyme and increases serum levels in neuron damage. The aim of the study is to evaluate neurological damage and analyze its effect on prognosis by considering S100β and NSE levels in liver transplantation.

Conditions

Liver Transplantation

Keywords

S100β; Neuron specific enolase; Liver transplantation

Outcome Measures

Primary Outcomes (3)

• Analyze S100β serum concentrations

  Blood sample is taken in preoperative period before induction of anesthesia in the operating room to analyze S100β serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis.

  before induction

• Analyze S100β serum concentrations

  Blood sample is taken first month in postoperative period to analyze S100β serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis

  first month

• Analyze S100β serum concentrations

  Blood sample is taken sixth month in postoperative period to analyze S100β serum concentrations and neurologic damage of liver transplantation patients besides evaluating its effect on prognosis.

  sixth month

Secondary Outcomes (3)

• Analyze Neuron specific Enolase serum concentrations

  before induction

• Analyze Neuron specific Enolase serum concentrations

  first month

• Analyze Neuron specific Enolase serum concentrations

  sixth month

Study Arms (2)

1

Healthy volunteers. Liver donor groups; Course of the research: Blood samples from all groups shall be taken for S100β and NSE in preoperative period, in the operating room and after 1 and 6 months in postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients who were transplanted liver with S100β and NSE. Demographic data of the patients, accompanying diseases, American Society of Anesthesia classification, etiology, Model For End-Stage Liver Disease score, Child classification, sodium, potassium, total bilirubin, alanine aminotransferase, aspartate aminotransferase, Alkaline phosphatase, International Normalized Ratio, creatinine and urea shall be recorded. Intraoperative medicine administration and fluid balance, duration of operation, graft hot ischemia and graft cold ischemia durations, initial pulmonary artery pressure, blood component transplantations shall be recorded.

Diagnostic Test: S100β and Neuron specific enolase (NSE)

2

Liver transplant groups;Course of the research Blood samples from all groups shall be taken for S100β and NSE in preoperative period, in the operating room and after 1 and 6 months in postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients who were transplanted liver with S100β and NSE. Demographic data of the patients, accompanying diseases, American Society of Anesthesia classification, etiology, Model For End-Stage Liver Disease score, Child classification, sodium, potassium, total bilirubin, alanine aminotransferase, aspartate aminotransferase, Alkaline phosphatase, International Normalized Ratio, creatinine and urea shall be recorded. Intraoperative medicine administration and fluid balance, duration of operation, graft hot ischemia and graft cold ischemia durations, initial pulmonary artery pressure, blood component transplantations shall be recorded.

Diagnostic Test: S100β and Neuron specific enolase (NSE)

Interventions

S100β and Neuron specific enolase (NSE) DIAGNOSTIC_TEST

S100β is 10.4 kDa protein. Synthesized with end feet processes of astrocytes in the brain S100β belongs to low molecular weight EF-hand type acidic calcium binding protein superfamily. This protein is metabolized in the kidneys and removed with urine. It is shown that S100β does not show differences due to ethnical groups or genders and is not affected by circadian rhythm. Although S100β is also found in other tissues, it is in higher concentrations in the brain so it can be used as an early indicator for brain damage.NSE is an SSS protein which exists in neurons and neuroendocrine tissues. NSE plays a role in glycolytic route in neurons as intracytoplasmic enzyme increasing serum level in case of neuron damage. Whilst S100β is the marker of astroglia dysfunction, NSE is the marker of neuronal dysfunction.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All living-made approximately 60 transplants shall be accepted.

You may qualify if:

• All liver transplantation candidates shall be accepted into the study.

You may not qualify if:

• Patients who:
• Refused the study With infection, oncological and hematological diseases, coronary or kidney failure, malnutrition or skull fracture The ones who were transplanted liver from cadaveric Using psychoactive medicine Having respiratory system or central nerve system disease shall be excluded from the study.

Sponsors & Collaborators

• Bora Dinc: lead

Study Sites (1)

Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation

Antalya, 07059, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

analyzing S100β and neuron specific enolase serum concentrations

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: March 5, 2018
• Study Start: June 20, 2017
• Primary Completion: March 1, 2021
• Study Completion: May 20, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)